Senior Specialist, Regulatory Affairs, Critical Care

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments.

Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.

Throughout our history, Edwards has helped transform the way physicians monitor and take preventative measures for cardio patients.

Our Critical Care business unit specializes in advanced hemodynamic monitoring solutions, including artificial intelligence algorithms to provide predictive readings to clinicians, helping them get patients home to their families faster.

It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

This role can be either an onsite or hybrid role based at Edwards’ Irvine campus.

How you will make an impact :

Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues;

also keeps management apprised of alternative actions. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.

• Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans
• Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions.

Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support.

e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files)

• Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process
• Review labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
• Other incidental duties

What you’ll need (Required) :

• Bachelor’s Degree in a related field and 5 years of previous related experience
• Master’s Degree in a related field and 3 years of previous related experience
• Coursework, seminar, and / or other formal government and / or trade association training

What else we look for (Preferred) :

• Bachelor’s or Master’s degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry)
• Experience in preparing EU design dossiers or technical files and US 510(k)s
• Full knowledge and understanding of EU and US regulations relevant to medical devices, Class II and / or Class III devices
• Full knowledge and understanding of EU and US requirements for product changes for disposable marketed products (catheters, minimally invasive sensors, pressure monitoring devices, blood management devices)
• Full knowledge of change management systems
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Excellent written and verbal communication skills including negotiating and relationship management skills
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Strict attention to detail

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $88,000 to $124,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Applications will be accepted while this position is posted on our Career website.

Edwards is an Equal Opportunity / Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination.

If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.

This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.